This Funding Opportunity Announcement invites applications
to establish Centers of Excellence for Self-Management Research: Building Research
Teams for the Future (P30). The purpose of the program is to enhance
interdisciplinary, biobehavioral research for scientists conducting self-management
research by enabling development of a sustainable research infrastructure and
centralized resources in support of research programs in various science
areas.

Key Dates

Posted Date

January 10, 2014

Open Date (Earliest Submission Date)

February 11, 2014

Letter of Intent Due Date(s)

February 11, 2014

Application Due Date(s)

March 11, 2014, by 5:00 PM local time of applicant
organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

AIDS Application Due Date(s)

March 11, 2014, by 5:00 PM local time of applicant
organization.

Applicants are encouraged to apply early to allow adequate
time to make any corrections to errors found in the application during the
submission process by the due date.

Scientific Merit Review

June/July 2014

Advisory Council Review

August 2014

Earliest Start Date

September 1, 2014

Expiration Date

March 12, 2014

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for
Submission Tracking (ASSIST) is available for the electronic preparation and
submission of multi-project applications through Grants.gov to NIH.
Applications to this FOA must be submitted electronically; paper applications
will not be accepted. ASSIST replaces the Grants.gov downloadable forms
currently used with most NIH opportunities and provides many features to enable
electronic multi-project application submission and improve data quality,
including: pre-population of organization and PD/PI data, pre-submission
validation of many agency business rules and the generation of data summaries
in the application image used for review.

Required Application Instructions

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH Guide for Grants and Contracts)
and where instructions in the Application Guide are directly related to the
Grants.gov downloadable forms currently used with most NIH opportunities.
Conformance to all requirements (both in the Application Guide and the FOA)
is required and strictly enforced. Applicants must read and follow all
application instructions in the Application Guide as well as any
program-specific instructions noted in Section
IV. When the program-specific instructions deviate from those in the
Application Guide, follow the program-specific instructions. Applications that
do not comply with these instructions may be delayed or not accepted for review.

This Funding Opportunity Announcement (FOA) invites
applications to establish Centers of Excellence for Self-Management Research
(P30). The purpose of the program is to enhance interdisciplinary,
biobehavioral research for scientists conducting self-management research by
enabling development of a sustainable research infrastructure and centralized
resources in support of research programs in these science areas:

(1) enhance research infrastructure by expanding and
targeting research resources available to promote and support self-management;

(2) expand the number and quality of research projects aimed
at improving self-management in (a) persons of all ages with chronic and acute
disorders, (b) persons with function-impairing symptoms and their caregivers,
or (c) projects aimed at improving health and quality of life in chronically
ill persons, including those with multiple chronic conditions;

(3) expand the number of research investigators involved in
interdisciplinary nursing science research;

(4) increase the quantity and quality of research projects
utilizing genetics/genomics, and biobehavioral methods;

(5) plan for and develop sustainability of research programs
by building an active and growing research program with collaborations and
partnerships both inside and outside of the applicant organization.

Self-Management Research

Chronic conditions impair the quality of life (QOL) of more
than 90 million Americans. Self-management has become an essential component of
disease management and a major goal for the 15%-20% of children and 80% of
older adults who have one or more chronic conditions.

Promoting self-management is essential across the lifespan.
In young people, chronic illness can be difficult, typically requiring the
engagement of both child and their parent(s) and sibling(s). Research
elucidating the best timing and means to transition children from partial to
full responsibility for self-management is critically needed. The economic and
QOL costs of chronic illness, disability, developmental delay, and behavior
problems in children and adolescents are devastating to families and are
predicted both to grow and be enduring. Research to improve family functioning
and QOL in the context of interventions designed to improve self-management in
children are key aims in the NINR Strategic Plan (https://www.ninr.nih.gov/sites/www.ninr.nih.gov/files/ninr-strategic-plan-2011.pdf).

Much of the self-management research to date has focused on
older populations. With the graying of America, the caregiving burden and costs
of chronic illness and disability in older adults has led to poor health.
Greater self-management of chronic conditions in middle aged adults may lessen
caregiver burden and decrease healthcare costs, and lead to the enhancement of
QOL and reduced disability as these adults age. Likewise, older adults may
acquire greater self-management skills, thus reducing or slowing their decline
and lessening the significant economic and financial burdens on care. In
addition, engagement in self-management does not assure good adherence (which
is known to reflect many different variables), poor understanding and poor
commitment to treatment regimens are known barriers to adherence.

Programs that are sustainable are needed for self-management
to improve quality of life of individuals
living with chronic illness. Self-management is intended to improve well-being
and strengthen self-determination and participation in health care, while
reducing health care utilization and health care costs. Research on the effects
of self-management, both on the individual with a chronic disorder, on those
around them, and on society at large must be developed in order to plan for the
health and wellbeing of the nation. Research to predict who will benefit from
self-management interventions is essential. Biobehavioral measures and new
research and intervention methods are needed to maximize the benefits of
self-management relative to the costs, both economic and psychosocial, of
illness.

NINR Centers

NINR currently supports a number of
Exploratory/Developmental Center (P20s) and Centers of Excellence (P30s)
grants.

The purpose of an NINR P30 Center is to: (1) develop
sustainable interdisciplinary, biobehavioral research capacity for scientists
conducting nursing research by establishing centralized research resources and
a research infrastructure; (2) advance the Center’s thematic science area
through complementary, synergistic research activities; and (3) enable
feasibility research that will develop into new programs of research and
independent investigator research applications.

It is expected that new biomedical and behavioral knowledge
will be discovered for improving self-management of persons with acute and
chronic disorders, and for improving the quality-of-life of all patients and
their caregivers, across the NINR research mission areas and strategies
presented in the 2011 NINR Mission and Strategic Plan (http://www.ninr.nih.gov/ AboutNINR/NINRMissionandStrategicPlan ).

Interdisciplinary and biobehavioral approaches to improve
understanding of self-management are needed as well as attention to health
disparities in self-management. Applicant organizations should submit nursing
research applications in areas specific to the self-management research areas
in the NINR strategic plan priority areas. Applicants are to select a topical
area for their application based on a conceptually sound integration of the
currently funded projects that comprise the research base of the Center.
Applications should propose innovative ideas consistent with NINR's mission.
Although not inclusive of all topics that would be considered responsive to
this FOA, applicants are encouraged to review the NINR’s Strategic Plan
document (http://www.ninr.nih.gov/AboutNINR/NINRMissionandStrategicPlan
/) that includes the following examples of Self-Management
areas of scientific opportunity at NINR:

Self-Management Areas of Opportunity

In creating a Center of Excellence designed to build
research teams of the future in self-management of chronic conditions, the
following areas of science may be considered but are not limited to:

Develop and/or implement technologies for the self-management of
symptoms of chronic illness.

Identify cost-effective strategies for self-management and
promotion of personal health among long-term survivors of disease and persons
with chronic disabilities, including routine health monitoring and attention to
co-morbid conditions.

Examine factors that impact sustainability of self-management
behaviors for individuals and families/caregivers dealing with chronic
conditions.

Develop strategies to improve self-management of chronic illness
across the lifespan, particularly in the context of comorbidities.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or
both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New

The OER
Glossary and the SF424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The National Institute of Nursing Research intends to
commit $2.1 million to support 2-3 awards from this P30 FOA and 2-3 awards
form the P20 FOA (RFA-NR-14-001).

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should
work with their organizational officials to either create a new account or to
affiliate an existing account with the applicant organization’s eRA Commons
account. If the PD/PI is also the organizational Signing Official, they must
have two distinct eRA Commons accounts, one for each role. Obtaining an eRA
Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct. Applicant
organizations with current P30 or P20 Center awards from NINR are only eligible
to apply to this FOA if, at the time of application, their total period of
Center support is less than eight (8) years and they have a research focus on
self-management research.

NIH will not accept any application that is essentially the
same as one already reviewed within the past thirty-seven months (as described
in the NIH
Grants Policy Statement), except for submission:

To an RFA of an application that was submitted previously as an
investigator-initiated application but not paid;

Of an investigator-initiated application that was originally
submitted to an RFA but not paid; or

Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants can access the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and
submit applications through Grants.gov to NIH. Applications prepared and
submitted using applicant systems capable of submitting electronic
multi-project applications to Grants.gov will also be accepted.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise and where instructions in the
Application Guide are directly related to the Grants.gov downloadable forms
currently used with most NIH opportunities. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows IC staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Additional page limits described in the SF424 Application
Guide and the Table of
Page Limits must be followed.

Instructions for the Submission of Multi-Component
Applications

The following section supplements the instructions found in
the SF424 (R&R) Application Guide, and should be used for preparing a
multi-component application.

The application should consist of the following components:

Overall: required

Administrative Core: required

Pilot Projects Core: required

Cores (Other): optional

Overall Component

When preparing your application in ASSIST, use Component
Type ‘Overall’.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other
components should be repeated in cell line table in Overall component.

Research & Related Other Project
Information (Overall)

Follow standard instructions.

Project
Summary/Abstract: Describe the scientific theme and goal of the
Center and provide a brief overview as it relates to the theme and goal of the
Center.

Project
Narrative: In 1-3 sentences describe the relevance of the
Center activities on public health.

Facilities
and Other Resources: Describe the existing environment and
facilities available to the Center and the process including fee structure to
access facilities.

The Institutional Commitment at the applicant
institution will be a major consideration in ensuring the goals of the Center.
The parent institution should recognize the Center as a formal organizational
component and provide documented evidence of space dedicated to the needs of
the Center, protected time to devote to Center activities, staff recruitment,
dedicated equipment, or other financial support for the proposed Center.

The parent institution should provide assurance of
its commitment to continuing support of the Center in the event of a change in
directorship and a well-defined plan for this eventuality should be in place.
In addition, it is expected that the Institution will support the goal of
providing to Center members’ priority access to Institution’s and Center’s
facilities and services at minimal or reduced cost.

Equipment: A general listing of major, shared pieces of equipment to be used by Center
members should be provided and the process including fee structure (if any) to
access shared equipment.

Other
Attachments: The following "Other Attachments" should
be included with the Overall Component in order to aid in the review of
applications. The filename provided for each attachment will be the name used
for the bookmark in the application image. All attachments need to be in pdf
format.

Center
Collaborations: Title this attachment “Center Collaborations” and organize
alphabetically by Center Member (last name, first name). List all Center
Members. Provide primary Department Affiliation, including location of research
space, key words for research interests, and names of any Center members who
have served as training mentors or long time research associates of said Center
member.

Project/Performance Site Location(s) (Overall)

Enter primary site only.

A
summary of Project/Performance Sites in the Overall section of the assembled
application image in eRA Commons compiled from data collected in the other
components will be generated upon submission.

Research & Related Senior/Key
Person Profile (Overall)

Include only the Project Director/Principal
Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the
entire application.

The PD/PI (overall Center Director) must be a
doctorally prepared nurse scientist currently employed at a school of nursing.

A
summary of Senior/Key Persons followed by their Biographical Sketches in the
Overall section of the assembled application image in eRA Commons will be
generated upon submission.

Budget (Overall)

The only budget information included in the Overall
component is the Estimated Project Funding section of the SF424 (R&R)
Cover.

A
budget summary in the Overall section of the assembled application image in eRA
Commons compiled from detailed budget data collected in the other components
will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific
Aims: Describe the specific aims of the Center, overall.

Research
Strategy: The application must:

Describe
the strategy by which the goals of the Center will be met

Describe
the relationship and lines of authority and sanction by appropriate
institutional officials. Specifically address administrative responsibilities
between the collaborating institutions, organizational components, faculty, and
staff.

Provide a
plan for ensuring the solvency of the proposed team once an award has been made
and for resolving conflicts between the Center Director and other Center
members.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct
costs requested for any one year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Note: The Project Performance Site form allows up
to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Administrative Core)

In the Project Director/Principal Investigator section of the
form, use Project Role of ‘Other’ with Category of ‘Core Director’ and provide
a valid eRA Commons ID in the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are
working in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

The
Center Director (PD/PI) must also be the Administrative Core Director.

The
complex nature of administrative requirements of centers will necessitate the
assistance of a person with business management expertise. It is
important that such an official is identified and is directly involved with the
fiscal aspects of the application and grant. An appropriate amount of this
individual's time and effort should be committed for this purpose. The
institutional business official should be a member of the Executive Committee.
While budget formulation and planning will undoubtedly begin with the Director
in collaboration with the scientific staff, the business official should be
involved in the process, provide consultation in matters of fiscal administration,
and evaluate such issues as equipment on hand versus that requested for the
Core facilities. Additionally, this institutional official can assist the
Center Director in determining the compliance with NIH research guidelines.

Budget (Administrative Core)

Budget forms appropriate for the specific component
will be included in the application package.

The Administrative Core Director must contribute no
less than 1.8 person months (15% time and effort) to the Core’s activities.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific
Aims: Describe the specific aims of the Administrative
Core.

Research
Strategy: The Administrative Core should manage the overall
activities of the Center, including developing, promoting, and managing use of
Center resources.

The Administrative Core must contain the following:

A general
description of activities and institutional support of the Core

A
description of the strategy by which the Administrative Core will enhance and
expand the self-management research community;

A
presentation of the administrative structure. Include the role of the
Administrative Core in 1) establishing and maintaining all collaborations, and
2) working with the institution and local regulatory bodies to ensure that
human subject or vertebrate animal research is in compliance with appropriate
regulations and guidelines governing animal use and studies involving human
subjects research.

The Administrative Core is responsible:

To review
utilization of funds, including funds for research Projects and other Core(s)
activities, and assure the appropriate expenditure of these funds

To
optimize the utilization of the shared resources of the Center, such as all
Core(s) resource.

For the
development and execution of an evaluation plan and a plan for sustainability.

It is expected that the Center’s Administrative
structure will accomplish the following:

Coordinate
and oversee the administrative functions of the Center;

Review
utilization of funds, including funds for research Projects and other Core(s)
activities, and assure the appropriate expenditure of these funds;

Plan for
the sustainability of the Center after the period of support is completed,
including development of collaboration(s) and preparation for seeking NIH R01
support.

Oversee
an Executive Committee, consisting of the heads of all Cores and appropriate
business official(s), which should be established to assist the Center Director
in the allocation of Center resources, the identification and selection of key
personnel, and the planning and execution of Center activities. Other members
can be added to the Executive Committee at the Director’s discretion.

Oversee
an External Advisory Committee (EAC) of scientists and administrators which should
be established and composed of at least two (2) scientists from outside the
applicant organization, with expertise and experiences relevant to the
scientific program of the Center. This committee should be used in evaluating
the overall research programs of the Center, the development and utilization of
research resources, the effectiveness of communications within the Center, and
any activities in which problems arise for which expertise is required or
desirable. The EAC should meet in person at least once annually. Each meeting
will have an appointed Chair. The meeting of the EAC minutes as well as a
response from the Center Director on meeting EAC recommendations must be
included in the yearly progress report.

The Center Director and other Center components, as
the Director deems appropriate, are responsible for the evaluation plan

The need for collecting appropriate data (such as
publications, presentations, grant awards, and other accomplishments that
accrue as a result of the Center activity and presence) is emphasized. This
will allow for annual planned evaluation of goals attainment and subsequent
medial action as needed. As a result of this guidance and the need of Centers
to ensure their own success, a plan for ongoing evaluation of progress toward
meeting the aims and goals of all Pilot Projects, and the overall Center are
required. This plan should include the specific criteria and methods that will
be used for the evaluation. The plan should specify the types of evaluation
information that will be submitted in the Center's annual progress report.

The Evaluation Plan should include

The
specific criteria and methods that will be used for the evaluation.

the
types of evaluation information that will be submitted in the Center's annual
progress report.

Measurable
goals for each project year relating to progress of each Core and research
Project, collaborative research activities, dissemination and impact of
knowledge gained from research projects, and efforts to facilitate
sustainability.

The plan
for evaluating progress, which must include maintaining a detailed record of
the research projects, oral and poster presentations and publications derived
from Center activity and funding, grant submission activity resulting from
Center activities, and collaboration by Center investigators with other schools
and institutions.

An
accounting of resources and resource utilization, as well as efforts taken to
maximize the research utilization of these resources.

A section
addressing sustainability of the Center and its research, including plans for
attracting new investigators and resources into Center research
activities.

An annual
assessment of goals achievement.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Administrative Core)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion
Enrollment Report (Administrative
Core)

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment
Report as described in the SF424 (R&R) Application Guide.

Pilot Projects Core

When preparing your application in ASSIST, use Component
Type ‘Core.’

Applications must propose a minimum of two Pilot Projects to
be started during the first year.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Pilot Projects Core)

In the
Project Director/Principal Investigator section of the form, use Project Role
of ‘Other’ with Category of ‘Core Director’ and provide a valid eRA Commons ID
in the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are
working in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

The Pilot Project Core Director must hold a doctorate
from a research training program (e.g., PhD) and be a faculty member or senior
investigator of equivalent rank at the applicant institution.

An eligible Pilot Project Investigator i includes:

A nurse
scientist investigator who has not been a PD(s)/PI(s) of a self-management
study in the past, or who is not currently funded by a DHHS research Project
grant (i.e., R01, R03, R15 or R21). If you are currently funded with other
mechanisms, such as R34, R41, R42, R43, R44 or any K awardee, you will still be
eligible.

An
established nurse scientist investigator (i.e. one currently funded by a DHHS
research Project grant (i.e., R01, R03, R15 or R21) who wishes to develop skill
and expertise in conducting self-management and for whom this area represents a
clear and distinct departure from his/her ongoing research interests. Strong
justification must be made in the application to include an established
investigator as a Pilot Project Investigator. Evidence that this project
represents a new research career path that will be sustained by the Pilot
Project Investigator is required.

The Center Director (PD/PI) and any of the Core
Directors may not serve as a Pilot Project Investigator.

Budget (Pilot Projects Core)

Budget forms appropriate for the specific component
will be included in the application package.

No one Pilot Project should constitute greater than
one third of the dollars allocated for Core projects.

Two research projects are required to be completed in
the first two years of the grant with new projects developed in subsequent
years with a minimum of 1-2 projects ongoing each year and must be developed
during the course of the award. They are intended to enable eligible
investigators to explore a scientific topic on self-management, and to amass
sufficient expertise and data to complete the study and develop an independent
research track and applications (e.g., NIH R01).

Pilot Projects cannot be used to supplement
already-funded research at the applicant organization.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Pilot
Projects Core)

Specific
Aims: Describe the specific aims of the Pilot Project Core

Research
Strategy: Applications must propose a minimum of two Pilot
Projects to be started during the first year and that are determined acceptable
by the reviewers. These two Pilot Projects must be undertaken and completed
during the first two years of Center grant support. Pilot projects should not
be used to fund phase 3 clinical trials. New projects must be developed in
subsequent years (with a minimum of 1-2 projects ongoing each year).

Each Pilot Project must follow these guidelines:

The
theoretical or conceptual basis for the pilot and/or feasibility studies must
be clearly explicated.

An
interdisciplinary approach is required to promote the collaboration of nurse
scientists with scientists of other disciplines as appropriate.

The
application must indicate how the proposed pilot/feasibility study fits within
the scientific area of nursing inquiry selected for the Center, and must tell
how the investigator satisfies the eligibility criteria

A
timeline for the initial 2 pilot projects must be submitted.

The Research Strategy for this core should include a
description of the process to select and review Pilot Projects. The Center
review process may be carried out by the Advisory Committee, by an ad hoc
Review Committee, by a mail review, or by a combination of these methods. It is
recommended that the Center Director use at least two scientists with expertise
relevant to the scientific area of inquiry of the Center from outside the
institution during the review process.

Human
Subjects and/or Vertebrate Animals: The center must include the
internal institutional plans and procedures to ensure that all projects
supported from this award will comply fully with all applicable Federal
regulations, policies, and Guidelines, including those for research involving
human subjects, including the evaluation of risks and protections in project
proposals and appropriate ethical oversight of funded projects. Human Subject
and Animal Subject approval dates for Pilot and Feasibility projects should NOT
be submitted with the application, but should be provided to NINR for approval
with Just in Time information, or prior to the start of the pilot project, and
with annual progress reports. Otherwise indicate in the appropriate section
that human subjects or vertebrate animals are not involved.

Common Data Elements: NINR encourages the use of
common data elements (CDEs) in basic, clinical, and applied research, patient
registries, and other human subject research to facilitate broader and more
effective use of data and advance research across studies. CDEs are data
elements that have been identified and defined for use in multiple data sets
across different studies. Use of CDEs can facilitate data sharing and
standardization to improve data quality and enable data integration from
multiple studies and sources, including electronic health records.

NIH ICs have identified CDEs for many clinical
domains (e.g., neurological disease), types of studies (e.g. genome-wide
association studies (GWAS)), types of outcomes (e.g., patient-reported
outcomes), and patient registries (e.g., the Global Rare Diseases Patient
Registry and Data Repository). NIH has established a “Common Data Element
(CDE) Resource Portal" (http://cde.nih.gov/)
to assist investigators in identifying NIH-supported CDEs when developing
protocols, case report forms, and other instruments for data collection. The
Portal provides guidance about and access to NIH-supported CDE initiatives and
other tools and resources for the appropriate use of CDEs and data standards in
NIH-funded research. Investigators are encouraged to consult the Portal and
describe in their applications any use they will make of NIH-supported CDEs in
their projects.

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Pilot
Projects Core)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion
Enrollment Report (Pilot Projects Core)

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.

Cores - Other

When preparing your application in ASSIST, use Component
Type ‘Core.’

Optional cores, including but not limited to a
Design/Methodology/Statistics Core, or a Biobehavioral Tools Core, may be added
to facilitate the achievement of goals and objectives. An important
consideration is the degree to which core facilities (a) will be utilized by
and benefit ongoing and/or proposed Projects and Center investigators and (b)
will assist in the development of the activities related to self-management
research.

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions, as noted.

Note: The Project Performance Site form allows up to
300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key
Person Profile (Cores - Other)

In the
Project Director/Principal Investigator section of the form, use Project Role
of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in
the Credential field.

In the
additional Senior/Key Profiles section, list Senior/Key persons that are
working in the component.

Include a
single Biographical Sketch for each Senior/Key person listed in the application
regardless of the number of components in which they participate. When a
Senior/Key person is listed in multiple components, the Biographical Sketch can
be included in any one component.

If more
than 100 Senior/Key persons are included in a component, the Additional Senior
Key Person attachments should be used.

A Core Director must hold a doctorate from a research
training program (e.g., PhD) and be a faculty member or senior investigator of
equivalent rank at the applicant institution

Budget (Cores - Other)

Budget forms appropriate for the specific component
will be included in the application package.

These items also need to be followed.

1. A Core Director must contribute no less than 1.8
person months (15% time and effort) to the Core’s activities.

2. Core budgets may not be used to supplement any
research project within or outside of the Center. Cores are not intended to function
as independent research projects, however, they may investigate the benefit of
the Core’s services/resources, or means of enhancing Core services/resource
provision.

3. No one core should constitute greater than one
third of the dollars allocated for Core projects.

Note:
The R&R Budget form included in many of the component types allows for up
to 100 Senior/Key Persons in section A and 100 Equipment Items in section C
prior to using attachments for additional entries. All other SF424 (R&R)
instructions apply.

PHS 398 Research Plan (Cores - Other)

Specific
Aims: Describe the specific aims of the Core.

Research
Strategy: The Research Strategy must include the following:

Description
of the Core service or resource, and evidence of need for Core

Demonstration
of the necessary expertise/resources to provide the services or materials
proposed

Evidence
of and plans for interaction with all Center Projects and other Center Cores

Plan for
and mechanism to announce availability of Core resources to the University, or
research community (i.e., beyond Center investigators)

A
mechanism to track the nature of each service exchange. (Note: Needing to also
track the amount/duration of each service exchange is listed in the Budget
Section above.)

Resource
Sharing Plan: Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424
(R&R) Application Guide, with the following modification:

All
applications, regardless of the amount of direct costs requested for any one
year, should address a Data Sharing Plan.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for
the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Cores -
Other)

When conducting clinical research, follow all
instructions for completing Planned Enrollment Reports as described in the
SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion
Enrollment Report (Cores - Other)

When conducting clinical research, follow all
instructions for completing Cumulative Inclusion Enrollment Report as described
in the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications
before the due date to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies) using ASSIST or other electronic submission
systems. Applicants must then complete the submission process by tracking the
status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically.

Important
reminders:All PD(s)/PI(s) and component Project Leads must include their
eRA Commons ID in the Credential fieldof the Senior/Key Person Profile
Component of the SF424(R&R) Application Package. Failure to register
in the Commons and to include a valid PD/PI Commons ID in the credential field
will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness by the Center for Scientific Review and responsiveness by components of participating organizations,
NIH. Applications that are incomplete and/or nonresponsive will not be
reviewed.

Post Submission Materials

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-13-030.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect
their assessment of the likelihood for the Center to exert a sustained,
powerful influence on the research field(s) involved, in consideration of the
following review criteria and additional review criteria (as applicable for the
project proposed).

Scored Review Criteria - Overall

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a Center that by its nature is not
innovative may be essential to advance a field.

Significance

Does the Center address an important problem or a
critical barrier to progress in the field? If the aims of the Center are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other
researchers well suited to the project? If Early Stage Investigators or New
Investigators, or in the early stages of independent careers, do they have
appropriate experience and training? If established, have they demonstrated an
ongoing record of accomplishments that have advanced their field(s)? If the Center
is collaborative or multi-PD/PI, do the investigators have complementary and
integrated expertise; are their leadership approach, governance and
organizational structure appropriate for the project?

Does the Center Director or Core Director have the
ability to provide scientific and administrative leadership and direction?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Will the Center make a unique contribution or fill a
significant gap in the area of Self-Management research? Will the Center
resources provide a unique contribution to the research infrastructure at the
applicant organization?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the Center?
Are potential problems, alternative strategies, and benchmarks for success presented?
If the project is in the early stages of development, will the strategy
establish feasibility and will particularly risky aspects be managed?

If the Center involves human subjects and/or NIH-defined clinical research, are
the plans to address 1) the protection of human subjects from research risks,
and 2) inclusion (or exclusion) of individuals on the basis of sex/gender,
race, and ethnicity, as well as the inclusion or exclusion of children,
justified in terms of the scientific goals and research strategy proposed?

Does the Center demonstrate a multi- and
inter-disciplinary biobehavioral approach appropriate for its goals? Is the
coordination among the Administrative Core, the optional Cores, and the Pilot
Projects adequately explained? Is there synergistic potential among the
Center’s research components? Is the evaluation plan likely to ensure the
advance of the Center research aims? Is there justification for each research
and Core component in terms of the overall goals of the Center? Will the plans,
as proposed, bring investigators into the Center from within and outside the
institution?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Does the Center have the technologies and capacity to
foster interdisciplinary, state-of-the-art, and innovative research? Does the
proposed Center have a sufficient base of NIH funded research directly relevant
to Self-Management research? Does the Center take advantage of the capability
of its research base to maximize scientific productivity, particularly through
interdisciplinary coordination and collaboration?

Review Criteria - Administrative
Core

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field.

Significance

Does the Admin Core address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the qualifications, experience, commitment and
administrative competence of the Administrative Core Director appropriate? Is
there an appropriate time and effort commitment made by the Administrative Core
Director? Is there evidence that the Administrative Core, other Cores, and
research Projects staff have worked closely together in the preparation of the
application and will continue to do so in meeting the proposed Center
objectives?

Has an investigator been named to head the evaluation
effort? Does this individual have the qualifications, experience, commitment
and competence to accomplish the task? Is there evidence that the researchers
and faculty of the Center have worked closely together in the preparation of
the evaluation and sustainability plan and will continue to do so in annually
evaluating progress?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Is the organizational structure adequately developed,
well reasoned and appropriate to the aims of the Center? Does the application
describe how day-to-day management of the Center will be accomplished? Are the
plans to facilitate and monitor attainment of Center objectives appropriate?
Are contractual and consortium arrangements adequately described, if
applicable? Are plans for Center scientific growth and development over the
Project period appropriate and adequately described? Are plans for sustainability
and long-term management of the Center appropriate?

Is the evaluation plan adequately developed, well
reasoned and appropriate to the aims of the Center? Does the application
describe how monitoring, tracking, and corrective adjustments in activity will
be determined or take place? Does this tracking accommodate the information
required for annual progress reports to NINR?

Does the evaluation plan include well-defined and
quantifiable outcome measures? Are the overall plans to facilitate and monitor
attainment of Center objectives appropriate? Does the evaluation include an
accounting of resources and resource utilization, as well as efforts taken to
maximize the research utilization of these resources? Does the evaluation plan
include plans for sustainability of the Center?

Environment

Is institutional commitment to the pursuit of
Self-Management research and other proposed activities, including provision of
resources, administrative authority and recognition, convincing? Is there
evidence of institutional commitment to incorporate and highlight the Center
and its activities at the institution level and beyond?

Review Criteria – Pilot
Projects Core

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be
judged likely to have major scientific impact. For example, a project that by
its nature is not innovative may be essential to advance a field.

Significance

Does the Pilot Projects Core address an important
problem or a critical barrier to progress in the field? If the aims of the
project are achieved, how will scientific knowledge, technical capability,
and/or clinical practice be improved? How will successful completion of the
aims change the concepts, methods, technologies, treatments, services, or
preventative interventions that drive this field?

Investigators

Are the Core Director, collaborators, and other
researchers well suited to the Pilot Projects Core? If Early Stage
Investigators or New Investigators, or in the early stages of independent
careers, do they have appropriate experience and training? If established, have
they demonstrated an ongoing record of accomplishments that have advanced their
field(s)? If the project is collaborative or multi-lead, do the investigators
have complementary and integrated expertise; are their leadership approach,
governance and organizational structure appropriate for the project?

Are the qualifications, experience, commitment and
competence of the Core Director appropriate? Is there an appropriate time and
effort commitment made by the Core Director? Is there evidence that the
researchers and faculty of the Core and the Projects and Administrative Core have
worked closely together in the preparation of the application relative to the
Core resources and will continue to do so in meeting the proposed Center
objectives?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or
methodologies, instrumentation, or interventions proposed?

Approach

Are the overall strategy, methodology, and analyses
well-reasoned and appropriate to accomplish the specific aims of the Pilot
Projects Core? Are potential problems, alternative strategies, and benchmarks
for success presented? If the project is in the early stages of development,
will the strategy establish feasibility and will particularly risky aspects be
managed?

Is the organizational structure adequately developed,
well reasoned and appropriate to the aims of the Core? Does the application
describe how day-to-day management of Core resources will be accomplished? Are
there plans to identify emerging Core resource needs of the Center and
applicant organization? Are Core plans appropriate to facilitate and monitor
attainment of Center objectives?

Does the Core enhance and complement the Center’s
scientific goals (i.e., is there a good “fit” of the Core to the Center)?

If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?

Environment

Will the scientific environment in which the work
will be done contribute to the probability of success? Are the institutional
support, equipment and other physical resources available to the investigators
adequate for the project proposed? Will the project benefit from unique
features of the scientific environment, subject populations, or collaborative
arrangements?

Is institutional commitment to the Core in its
pursuit of resources to support Self-Management research, including provision
of resources and recognition, convincing?

Review Criteria - Optional Cores

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact. For example, a project that by its nature is not
innovative may be essential to advance a field

Significance

Does the Core address an important problem or a
critical barrier to progress in the field? If the aims of the project are
achieved, how will scientific knowledge, technical capability, and/or clinical
practice be improved? How will successful completion of the aims change the
concepts, methods, technologies, treatments, services, or preventative
interventions that drive this field?

Investigator(s)

Are the qualifications, experience, commitment and
competence of the Core Director appropriate? Is there an appropriate time and
effort commitment made by the Core Director? Is there evidence that the
researchers and faculty of the Core and the Projects and Administrative Core
have worked closely together in the preparation of the application relative to
the Core resources and will continue to do so in meeting the proposed Center
objectives?

Innovation

Does the application challenge and seek to shift
current research or clinical practice paradigms by utilizing novel theoretical
concepts, approaches or methodologies, instrumentation, or interventions? Are
the concepts, approaches or methodologies, instrumentation, or interventions
novel to one field of research or novel in a broad sense? Is a refinement,
improvement, or new application of theoretical concepts, approaches or methodologies,
instrumentation, or interventions proposed?

Approach

Is the organizational structure adequately developed,
well reasoned and appropriate to the aims of the Core? Does the application
describe how day-to-day management of Core resources will be accomplished? Are
there plans to identify emerging Core resource needs of the Center and
applicant organization? Are Core plans appropriate to facilitate and monitor
attainment of Center objectives?

Does the Core enhance and complement the Center’s scientific
goals (i.e., is there a good “fit” of the Core to the Center)?

Environment

Is institutional commitment to the Core in its
pursuit of resources to support Self-Management research, including provision
of resources and recognition, convincing?

Additional Review Criteria - Overall

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Guidelines
for the Review of Human Subjects.

Inclusion of Women, Minorities, and
Children

When the proposed project involves human subjects
and/or NIH-defined clinical research, the committee will evaluate the proposed
plans for the inclusion (or exclusion) of individuals on the basis of
sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of
children to determine if it is justified in terms of the scientific goals and
research strategy proposed. For additional information on review of the
Inclusion section, please refer to the Guidelines
for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound research
including the use of analgesic, anesthetic, and tranquilizing drugs and/or
comfortable restraining devices; and 5) methods of euthanasia and reason for
selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable

Renewals

Not Applicable

Revisions

Not Applicable

Additional Review Considerations - Overall

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Applications from Foreign
Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the National
Institute of Nursing Research, in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in
response to this FOA.

Applications will be assigned to the appropriate NIH
Institute or Center. Applications will compete for available funds with all
other recommended applications submitted in response to this FOA. Following
initial peer review, recommended applications will receive a second level of
review by the National Advisory Council for Nursing Research (NACNR). The
following will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH will
request "just-in-time" information from the applicant as described in
the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The awardee institution will provide NIH with specific plans for
data and safety monitoring, and will notify the IRB and NIH of serious adverse
events and unanticipated problems, consistent with NIH DSMP
policies.

When multiple years are involved, awardees will be required
to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR)
annually and financial statements as required in the NIH
Grants Policy Statement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the NIH Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and
405 of the Public Health Service Act as amended (42 USC 241 and 284) and under
Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.